Kornimate/medical-research-clean huggingface dataset:
an observational study to assess change in disease activity and adverse events in adult participants with moderate to severe active crohn's disease (cd)

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is an incurable chronic inflammatory disorder of the gastrointestinal tract. this study will assess how safe and effective risankizumab is in treating moderately to severely active cd in real world. adverse events and change in disease activity will be assessed. risankizumab is a drug approved for the treatment of cd. all study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. approximately 1000 participants will be enrolled worldwide. participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 36 months. there is expected to be no additional burden for participants in this trial. study visits may be conducted on-site or virtually as per standard of care.


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of crohn's disease (cd) confirmed by clinical, endoscopic and/or histological indices. * participants initiating risankizumab at the clinician's discretion as part of their routine clinical care. * participants prescribed risankizumab in accordance with the approved local label. * participants able to understand and communicate with the investigator and comply with the requirements of the study. * participants willing and able to provide authorization to use and disclose personal health information. * participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone). exclusion criteria: * females who are pregnant or breast feeding at baseline. * participants with any contraindication to risankizumab. * participants previously exposed to risankizumab. * participants currently participating in an interventional clinical trial.

Keywords: crohn's disease cd risankizumab
safety and efficacy of cocktail periarticular injection in simultaneous total knee arthroplasty

Conditions: Pain, Postoperative

Summary: we investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.

it is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty. a prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral tka and observing their postoperative analgesic consumption, visual analog scores and functional recovery. potential side-effects of the multimodal drugs is also under observation.

Eligibility criteria:
inclusion criteria: * patients with tricompartmental knee disease undergoing simultaneous bilateral tka exclusion criteria: * diabetes mellitus * neuromuscular deficit * a known allergy to one of the drugs being injected * a history of cardiac disease or arrhythmia requiring special monitoring

Keywords: total knee arthroplasty cocktail analgesia morphine consumption
bioequivalence of two formulations of biphasic insulin aspart 50 in japanese subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in japan. the aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (nn-x14mix50) in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * bmi (body mass index) between 19-29 kg/m\^2 (both inclusive) * fasting blood glucose between 3.8-6.0 mmol/l (both inclusive) * non-smokers exclusion criteria: * subjects with a first-degree relative with diabetes mellitus * subjects smoke 5 cigarettes or more per day
study of post-exposure ingavirin® prophylaxis of influenza and acute respiratory viral infections

Conditions: Influenza, Human; Acute Respiratory Infection; Common Cold; Flu; Viral Infection

Summary: the purpose of the study was to evaluate efficacy of prophylactic ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections

the study includes 7 days of treatment period and 30 days of follow-up, 37 days total. the participant was receiving ingavirin or placebo for 7 days. then during 30 days the participant was under supervision. visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period. wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. medical care was established for 10±2 days since symptoms. everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease. the patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary. wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.

Eligibility criteria:
inclusion criteria: * participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season * first exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours * signed informed contest to participate in the study * contraception throughout the study exclusion criteria: * interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion * anti-virals intake, other then investigational drug, throughout the study * vaccination for influenza less than 1 year before inclusion * pregnant or lactating

Keywords: profilaxis ingavirin
metabolic effects of stevia in type 2 diabetic patients

Conditions: Diabetes Mellitus

Summary: the main aim of the study is to assess the short term and 1-month metabolic effects of stevia rebaudiana bertoni in patients with type 2 diabetes.

this is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. the study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio. the intervention is made of two phases including 1. a mixed meal tolerance test with and without 240 mg of stevia in a randomized order to evaluate the acute effects; 2. an oral intake of 240 mg of stevia within 30 days as food supplement in order to assess medium-term effects

Eligibility criteria:
inclusion criteria: * known type 2 diabetes * unchanged hypoglycaemic treatment for at least 3 months prior to inclusion * no acute complication of diabetes * hba1c≤ 8% exclusion criteria: * infection up to 10 days prior to inclusion * serum alat \>3n, * mdrd estimated creatinine clearance \<60ml/min * tobacco smoking

Keywords: diabetes stevia insulin secretion insulin sensitivity sweetener
therapeutic effect of two fluoride varnishes on white spot lesions: a clinical study

Conditions: Dental Caries

Summary: the study hypothesis is the difference in therapeutic effect of two varnish formulations (g1 = naf, 2.26%f, g2 = naf, 2.71% f + caf2). these products are commercially available in the brazilian and international market and they are used for dental caries as white spot lesions control.

the aim of this study was to evaluate the therapeutic effect of two varnish formulations (g1 = naf, 2.26%f, g2 = naf, 2.71% f + caf2) on the remineralization of white spot lesions (wsl). the sample was composed of 15 (7- to 12-year-old) children with 45 active wsl in anterior permanent teeth. the children were randomly divided in two groups providing 22 lesions for g1 and 23 for g2. the children were submitted to weekly varnish applications 4 times. the wsl were evaluated twice: baseline and on week 4. maximum lesion dimensions (mesial-distal and incisal-gingival) were measured in millimeters and classified in four grades of size. wsl were also recorded assessing lesion activity by one calibrated examiner. the pearson chi-square and fisher's exact tests were used (p \ 0.01). it can be concluded that after 4 applications the two varnish formulations tested produced similar clinical effects indicating the reduction and the control of carious activity in most wsl.

Eligibility criteria:
inclusion criteria: * regular hygiene habits (brushing teeth everyday) * registered in public schools exclusion criteria: * dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth) * development enamel alterations (hypoplasia, fluorosis) or periodontal disease * children using orthodontic devices * under medical treatment * taking any kind of medicine * no informed consent form signed

Keywords: white spot lesion tooth remineralization fluoride varnishes
mindfulness based cognitive therapy for chronic pain and comorbid unipolar depression

Conditions: Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder NOS; Chronic Pain

Summary: the primary aim of this study is to test the feasibility and efficacy of mindfulness based cognitive therapy (mbct) training for the treatment of depressive symptoms in patients with chronic pain. the study also aims to elucidate the mechanisms underlying mbct on a psychological and neurobiological level. for this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. moreover this study involves optional fmri scans of the brain and blood measures before and after the intervention. main hypotheses: 1. the mbct training will be a feasible intervention in patients with chronic pain and co-morbid depression as defined by no occurrence of serious adverse events related to the intervention and a retention rate of more than 70% in the subjects assigned to the mbct arm. 2. patients who have completed the mbct training will demonstrate a significant decrease in depressive symptoms as measured on the quick inventory of depressive symptomatology - clinician rated (qids-c16), and the hamilton rating scale for depression (hrsd17) (qids-c/hrds) severity scale for depressive symptoms (the primary outcome measure), compared to the control group.


Eligibility criteria:
inclusion criteria: * the presence of chronic pain, which has persisted for at least 3 months. * meets criteria of major depressive disorder, dysthymic disorder or depressive disorder nos as defined by dsm-iv criteria. * have a minimum score of depressive symptoms of \> 10 as rated on the qids-c, administered during the screen. * able to provide written informed consent. * adults 18 years or older * english-language literacy. exclusion criteria: * serious suicide or homicide risk, as assessed by evaluating clinician. * severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease for which hospitalization is likely to be required within the next half year. * the following dsm-iv disorders: any bipolar disorder (current or past), current psychotic symptoms, or a primary psychotic disorder (current or past). entry of patients with anxiety disorder will be permitted if the depressive disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. * active diagnosis of substance abuse or dependence disorders within the last 3 months.
effects of steroid tapering on functional capacity and neurocognition

Conditions: Glioblastoma Multiforme

Summary: purpose and objective: 1. to compare the effects of either an abbreviated or protracted taper of dexamethasone on functional capacity in newly diagnosed glioblastoma multiforme (gbm) patients. 2. to compare neurocognitive function in newly diagnosed gbm patients receiving either an abbreviated or protracted taper of dexamethasone. 3. to compare skeletal muscle strength in newly diagnosed gbm patients receiving either an abbreviated or protracted taper of dexamethasone. 4. to examine the association between functional capacity and neurocognitive function and patient-reported measures (i.e. quality of life, fatigue, etc.) in newly diagnosed gbm patient on either an abbreviated or protracted taper of dexamethasone. 5. to examine the association between functional capacity and neurocognitive function and body composition measures (body-mass index, etc.) in newly diagnosed gbm patient on either an abbreviated or protracted taper of dexamethasone. 6. to examine the association between functional capacity and neurocognitive function and biochemical metabolic measurements in newly diagnosed gbm patient on either an abbreviated or protracted taper of dexamethasone. all study endpoints will be assessed at three timepoints as follows: (1) initial assessment after surgery in the hospital, (2) second assessment at initial clinical visit at the preston robert tisch brain tumor center (prt-btc) at duke, approximately 1 week post-operatively, and (3) third assessment at second clinical visit in the prt-btc at duke, approximately 10 weeks post-operatively and after completion of radiotherapy. an additional fourth assessment will be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at duke.

the proposed study is a randomized controlled trial. after obtaining written informed consent, all participants will be randomized to either an abbreviated (14 days) or protracted (30 days) course of dexamethasone post-operatively.

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to beginning specific protocol procedures, 2. histologically proven gbm, 3. status-post gross total resection or subtotal resection as indicated by \< 2 cm of residual enhancing disease (subjects with unresectable, multifocal, and /or bulky disease will be excluded), 4. \>18 years and \<70 years of age, 5. karnofsky performance index \>70%, 6. no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease, 7. no contraindications to a 6-minute walk test, 8. no contraindications to neurocognitive testing, 9. primary treating physician approval, and 10. no complications operatively or postoperatively that requires modification of dexamethasone dosing. 11. receiving dexamethasone as standard of care.

Keywords: randomized dexamethasone abbreviated protracted post-operatively
the sinopsys lacrimal stent for lacrimal system repair in epiphora

Conditions: Epiphora

Summary: prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the sinopsys lacrimal stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.

up to 10 patients will be enrolled and followed for six months. the primary objective is to demonstrate the safety and clinical performance of the sinopsys lacrimal stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. the primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.

Eligibility criteria:
inclusion criteria: * clinically significant functional epiphora for at least three months * keros classification 1 or 2 skull base anatomy exclusion criteria: * active infection * craniofacial deformity * severe inflammatory disease

Keywords: epiphora lacrimal stent lacrimal system
evaluation of essential metal metabolism

Conditions: Disturbance of Consciousness; Alteration of Metabolism; Essential Metals

Summary: disturbance of consciousness (doc) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness. it is known that the main causes of disorders of consciousness have important effects on the disruption of essential metal homeostasis. in particular, myocardial infarction and heart failure, ischemic and hemorrhagic stroke and head trauma trigger phenomena of diffuse axonal damage, hypoxia and re-perfusion that profoundly alter the metabolism of cerebral o2 that reacts with essential metals , in fenton-type reactions whose predominant effect is an extensive production of reactive oxygen species (ros) and pro-oxidant molecules. fe, cu and zinc (zn) are essential metals for life: two thirds of the proteins in our body use these metals that play a crucial role as catalysts or structural elements of proteins in various biological processes, such as cellular respiration in mitochondria, the production and maturation of red and white blood cells, the elasticity of connective tissue, the production of myelin and the production of some neurotransmitters. for this reason, the biology of essential metals has a major impact on our health and the disruption of their homeostasis inexorably leads to disease. these metals are very important for the metabolism of the central nervous system (cns) and cu, in particular, even in adults, is involved in the production of myelin and in the production of some neurotransmitters of the diffuse modulatory systems . cu is a cofactor of the enzymes dopamine β-hydroxylase, and monoamine oxidase involved in the balance of catecholamines , and is altered in some disorders of cu metabolism.


Eligibility criteria:
inclusion criteria: * patients who have been in a coma state, documented with a gcs ≤ 8 for at least 24 hours; * presence of a disturbance of consciousness, identified through the coma recovery scale-revised (crs-r) and classified as coma, vegetative state or minimally conscious state; * latency of the acute event between 15 days and 6 months; * ability of the caregiver/guardian to understand and sign the informed consent. exclusion criteria: * age \<18 years; * psychiatric or other pathologies; * inflammatory state related to ongoing infections; * refusal or inability to sign the written informed consent to participate in the study.

Keywords: patients with disturbance of consciousness essential metal metabolism status
effect of eleclazine (gs-6615) on exercise capacity in subjects with symptomatic hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the primary objective of this study was to evaluate the effect of eleclazine (gs-6615) on exercise capacity as measured by peak oxygen uptake (vo2) achieved during cardiopulmonary exercise testing (cpet), in participants with symptomatic hypertrophic cardiomyopathy (hcm).


Eligibility criteria:
key inclusion criteria: * established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis * exertional symptoms including at least one of the following: * new york heart association (nyha) class ≥ ii dyspnea * canadian cardiovascular society (ccs) class ≥ ii angina * screening (baseline) peak vo2 \< 80% of predicted for age, sex, and weight * ability to perform an upright treadmill cardiopulmonary exercise test (cpet) key exclusion criteria: * known aortic valve stenosis (moderate or severe) * known coronary artery disease * left ventricular systolic dysfunction (ejection fraction \< 50%) * recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hypertrophic cardiomyopathy hcm hocm hypertrophic myocardiopathy hypertrophic obstructive cardiomyopathies cardiomyopathy hypertrophic familial hypertrophic cardiomyopathy genetic heart disease echocardiography cardiopulmonary exercise testing exercise capacity heart failure angina dyspnea diastolic dysfunction microvascular ischemia late sodium current inhibitor gs-6615 late ina
the study of warfarin maintenance dose in chinese patients

Conditions: Atrial Fibrillation; Heart Valve Disease; Pulmonary Artery Embolism

Summary: 1. title: clinical study of the relationship between pharmacogenomics and warfarin dose in chinese patients 2. drug: warfarin 3. design: to value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the chinese patients. 4. hypothesis:pharmacogenomic algorithm guided dose can help to predict warfarin dose in chinese patients.

* for the patients who need to use warfarin, detect the "vitamin k epoxide reductase complex subunit 1 (vkorc1),cytochrome p450 2c9 (cyp2c9), and cytochrome p450 4f2 (cyp4f2) genotype. * record the demographic information: gender, age, height, and weight. * record drug combination, complications, and international normalized ratio (inr), liver function and kidney function or other biochemical test results. * put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.

Eligibility criteria:
inclusion criteria: * chinese patients * age \>18y * target inr 1.5\~3.0 * patients signed informed consent exclusion criteria: * has hemorrhage disease, or tendency to significant bleeding * severe liver and kidney disfunction, serious infections, severe heart failure (nyha heart function classification ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease * patients with pregnancy or lactation; * with cognitive impairment.

Keywords: gene guided warfarin dose chinese